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Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)

This study has been completed.
Sponsor:
Collaborators:
Mukoviszidose Institut gGmbH
Heidelberg University
Information provided by:
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00760071
First received: September 24, 2008
Last updated: April 14, 2010
Last verified: April 2010

September 24, 2008
April 14, 2010
July 2006
October 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00760071 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)
Evaluation of Morphological and Functional Magnetic Resonance Imaging (MRI) for Early Diagnosis of Lung Changes in Children (0-6 Years) With Cystic Fibrosis (CF)

In patients with Cystic Fibrosis (CF) the clinical course of lung disease is crucial for individual prognosis and life expectancy.

Imaging modalities are important in the assessment of follow up of structural lung changes and monitoring of pulmonary complications in CF. Although high resolution computed tomography (HRCT) is the accepted gold standard for evaluation of morphological lung changes in CF, chest-X-ray is widely used as standard imaging procedure for assessment and follow up in these young patients due to less radiation exposure.

Magnetic resonance imaging (MRI) has not been used for lung imaging in CF so far. Studies from the 80's and early 90's were not able to show any impact for the use of MRI in CF. Due to recent technical developments MRI of the lung became possible.

Our study group was able to show that MRI is a competitive imaging modality for evaluating changes of the CF-lung in comparison to the gold standard (HRCT).

So far only patients from the age of 6-7 years were examined. According to recent studies CF is a disease which starts in utero. Therefore it can lead to extensive pulmonary changes even in infants and young children. In this age group lung function testing is difficult and not broadly available. An early optimized therapy is crucial for the long term course and outcome of the pulmonary disease.

The aim of this study is to evaluate morphological and functional MRI for early diagnosis of lung changes in children (0-6 years) with CF.

Month 1-2: Protocol adaptation for infants and small children Month 3-14: Patient examinations (20 Patients with sedation) Month 15-18: Data evaluation

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

Diagnosed CF-patients (male/female), age 0-6 years

  • Cystic Fibrosis
  • Lung Disease
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  • 1CF-patients<6
    Patients with diagnoses of cystic fibrosis from birth to the age of 6 years
  • 2 controls
    age matched controls
Wielpütz MO, Puderbach M, Kopp-Schneider A, Stahl M, Fritzsching E, Sommerburg O, Ley S, Sumkauskaite M, Biederer J, Kauczor HU, Eichinger M, Mall MA. Magnetic resonance imaging detects changes in structure and perfusion, and response to therapy in early cystic fibrosis lung disease. Am J Respir Crit Care Med. 2014 Apr 15;189(8):956-65. doi: 10.1164/rccm.201309-1659OC.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent signed by the parents or a legal guardian
  • Sedation as necessary
  • Conventional clinical indicated diagnostic procedures (lung function test, chest-X-ray, CT)

Exclusion Criteria:

  • Study exclusion in case of contra indications for MRI:

    • Patients with cardiac pace maker, metallic implants (e.g. cerebral vessel clips) as well as other conditions that prohibit the exposition of a patient to a strong magnetic field.
    • No informed consent
    • Dyspnea, which disables the patient to follow breathing instructions during the study.
Both
up to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00760071
387/2005
Yes
German Cancer Research Center, Helmholz society
German Cancer Research Center
  • Mukoviszidose Institut gGmbH
  • Heidelberg University
Principal Investigator: Michael Puderbach, MD German Cancer Research Center
German Cancer Research Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP